Instrument for internal organ biopsy

ABSTRACT

Biopsy needle means particularly adapted for the withdrawal of tissue through a cannula forced through or along an unnatural route into the interior of a live body or organ such as thyroid, spleen, or a tumor mass, the means comprising, in combination, a biopsy needle including a generally hollow axially flexible elongated needle having a generally uniform cylindrical configuration with an internal core of substantially constant internal diameter extending throughout the major portion of the axial length of the needle, said needle having a tapered distal tip with a cutting surface formed along the edges of the tip, the needle having substantial axial flexure, stylet means having an external configuration generally matching the configuration of said core and arranged to be received within the core of said hollow needle, the stylet means comprising a rigid shaft having a closed sharp tip arranged to extend distally from the tapered distal tip when the stylet is received within the core of the hollow needle. In addition, the biopsy needle means is provided with a sheath which has substantial axial flexure for accommodating relative motion of various organs within the body, and reducing or eliminating the occurrences of bleeding complications.

United States Patent Khosrow Jamshidi 3146 Minnehaha Ave., Minneapolis, Minn. [21] Appl. No. 841,276

[22] Filed July 14, 1969 [45] Patented Dec. 28, 1971 [72] Inventor [54] INSTRUMENT FOR INTERNAL ORGAN BIOPSY 10 Claims, 9 Drawing Figs.

52 U.S.Cl 128/28, 128/303.17,128/310,128/347 511 1.11.0 A6lbl0/00, A61b17/36 so FieldofSearch [ZS/2,28,

171,975 11/1965 U.S.S.R.....

OTHER REFERENCES The Lancet, March 13, 1965, p. 585.

Primary ExaminerRichard A. Gaudet Assistant Examiner- Kyle L. Howell Attorney-Orrin M. Haugen ABSTRACT: Biopsy needle means particularly adapted for the withdrawal of tissue through a cannula forced through or along an unnatural route into the interior of a live body or organ such as thyroid, spleen, or a tumor mass, the means comprising, in combination, a biopsy needle including a generally hollow axially flexible elongated needle having a generally uniform cylindrical configuration with an internal core of substantially constant internal diameter extending throughout the major portion of the axial length of the needle, said needle having a tapered distal tip with a cutting surface formed along the edges of the tip, the needle having substantial axial flexure, stylet means having an external configuration generally matching the configuration of said core and arranged to be received within the core of said hollow needle, the stylet means comprising a rigid shaft having a closed sharp tip arranged to extend distally from the tapered distal tip when the stylet is received within the core of the hollow needle. in addition, the biopsy needle means is provided with a sheath which has substantial axial flexure for accommodating relative motion of various organs within the body, and reducing or eliminating the occurrences of bleeding complications.

PATEuTEnniczanm 3630.192

jg. 2 20 I fl2i Fl 6 60 6| J TO SOURCE OF 1 ELECTRICAL POWER 7 7o j 7 H v WNW 72 TO CRYOGENIC SOURCE INVENTOR KHOSROW JAMSH/D/ ATTORNEY INSTRUMENT FOR INTERNAL ORGAN BIOPSY The present invention relates to an improved biopsy needle means, and more particularly to a biopsy needle stylet-sheath means which is particularly adapted for use in the obtaining of biopsy samples from certain floating organs or the like such as, for example, thyroid, spleen or a tumor mass. Frequently, during the performance of biopsies, biopsy needle means are generally inserted through a cannula formed by forcing the needle means along or through an unnatural route into the interior of the patients body. If relative motion occurs along the cannula while the needle is present, the soft tissue organs such as thyroid, spleen, or tumor mass may suffer bleeding complications.

Biopsies may be taken by a number of procedures, including, for example, open surgery or percutaneous biopsy techniques. On certain occasion, however, percutaneous biopsies of organs such as thyroid, spleen, or tumor mass may be avoided and resort will be 'had to operative surgical procedures which, as indicated are generally more time consuming, require greater surgical skill, and may require the performance of major surgical steps. When it is desired to reveal the pathology of certain other organs such as liver, kidney and lungs through the simple percutaneous biopsy techniques, the occurrence of certain bleeding disorders in such patients render the percutaneous biopsy of such organs with presently available needles either impossible or dangerous due to the fear of bleeding complications. Also, if percutaneous procedures are utilized for obtaining biopsies from lungs, liver, kidney and spleen, these procedures must be taken rapidly, since these organs tend to move relative to other parts of the body due to respiration or other movements of the patient, and there may accordingly be danger of laceration and bleeding unless the biopsies are taken within the limited time and tolerance of the patient for avoiding respiration and holding their breath. Also, it may be important in certain patients to be able to obtain adequate biopsy material without bringing about structural damage of the tissue obtained from within the patients body, which, if damaged, may make proper examination and diagnosis difficult to achieve. On other occasions, it may be desirable to aspirate tissue or blood samples from an organ aside from taking abiopsy through a single procedure.

The biopsy needle means of the present invention may be fabricated from flexible material of variable length and caliber, the length and caliber being determined by the specific end need of the device. The distal end is beveled or tapered, and the beveled edge is sharpened in order to facilitate cutting into the organs pertinent to the biopsy. The interior of the needle is hollow, and the distal end of the hollow core is also tapered gradually with increasing caliber toward the proximal end of the needle in order to render it possible to obtain adequate material for purposes of the biopsy. This tapering structure prevents crushing of the tissue material, and accordingly eliminates the tendency toward structural damage of the tissues lodged in the needle due to the taper. The tissue material as recovered in the distal end of the needle is also entrapped and thus resistant to escape from the distal end of the needle as the needle is being pulled out. The features of the tapered distal end are disclosed in detail in my copending application Ser. No. 803,199, filed Feb. 28, I969, and entitled Biopsy Needle.

The sheath is also made of flexible material, thus accommodating the use of the device in nonfixed movable organs. The sheath is made so as to exactly fit the outer surface of the biopsy needle device to a point slightly below the beveled tip of the biopsy needle. The proximal end of the sheath may be modified, as desired to fit a syringe for aspiration purposes of the organs involved. The structure further includes a stylet which is made of hard material such as stainless steel or the like so as to fit within the biopsy needle with a sharp tip to extend beyond the beveled tip of the needle approximately l to 2 millimeters as desired.

If desired, a probe of hard material such as stainless steel as is conventional, may be utilized to remove the biopsy material from the interior core of the needle the probe being introduced from the distal end.

The apparatus of the present invention is further particularly adaptable forum with a microcauter, the microcauter being made of flexible heat or cold resistant material. Means are provided for coupling the microcauter to a source of electrical current, although batteries may be utilized to supply power, if required. The microcauter is fabricated so as to fit within the biopsy sheath with the tip extending a few millimeters beyond the distal end of the sheath. As an alternative, a cryoprobe may be utilized in lieu of the microcauter. The cryoprobe is preferably made of flexible metal and is adapted to fit within the sheath with its tip extending a few millimeters beyond the distal end of the sheath. It is provided with means for coupling to a source of extreme low temperature material such as, for example, liquid nitrogen or the like.

If desired, a guard may be utilized for accommodating a measured insertion depth for the biopsy structure, a suitable set screw means or the like being provided to accomplish the' setting at a predetermined distance from the tip of the needle. This will be accomplish penetration of the organ desired.

Therefore, it is an object of the present invention to provide an improvedbiopsy needle means which provides an axially flexible needle means with an axially flexible sheath, the apparatus being particularly adapted for use in the taking of biopsies from relatively soft or movable organs.

It is a further object of the present invention to provide an improved biopsy needle means which permits the taking of biopsies from a plurality of organs, including floating or relatively movable organs, the system being particularly adapted to the taking of percutaneous biopsies.

Other and further objects of the present invention will become apparent to those skilled in the art upon a study of the following specification, appended claims, and accompanying drawings wherein:

FIG. I is an elevational view of the biopsy needle means fabricated in accordance with the present invention, and illustrating the sheath, needle, stylet, and guard in proper operating disposition;

FIG. 2 is a detail elevational view of the needle portion of the apparatus shown in FIG. I;

FIG. 3 is a detail elevational view of the sheath portion of the apparatus, this figure illustrating a modified form of proximal end;

FIG. 4 is a detail elevational view of the stylet portion of the apparatus shown in FIG. 1;

FIG. 5 is a detail view of a probe which may be utilized to remove material from the core of the needle illustrated in FIG.

FIG. 6 is a detail elevational view of a microcauter apparatus which may be utilized in connection with the sheath means shown in FIGS. 1 and 3;

FIG. 7 is a detail elevational view of a cryoprobe which may be utilized in combination with the sheath means shown in FIGS. I and 3;

FIG. 7A is a detail view, on an enlarged scale. showing a broken away segment of the shaft of the cryoprobe of FIG. 7; and

FIG. 8 is a detail elevational view of a sheath having a modified proximal end, such as is shown in the apparatus of FIG. 1.

In accordance with the preferred modification of the present invention, and particularly as is illustrated in FIG. I, the biopsy needle means of the present invention generally designated 10 includes an outer sheath manner II, the sheath retaining coaxially therewithin, the biopsy needle I2, along with the interiorly disposed stylet 13. Also, on the outer surface of the sheath 11, there is received a guard member 14 which is secured firmly to a sleeve 15, sleeve 15 being axially slidable along the extent of the sheath II and arranged to be secured in place by means of locking screw I6.

Turning now to the detail of the needle portion I2, it will be seen that the needle 12 comprises a generally hollow sleeve member 20 having a distal end portion 21 and a proximal end 22. The distal end is gradually tapered at the tip end thereof, for approximately 2 to 3 centimeters in order to accommodate cutting into the organs involved. Also, the beveled edge is made quire sharp in order to facilitate cutting into the organs involved. The inner core of the needle is also tapered at the distal end in order to accommodate material that is gathered in the course of the biopsy, and permit this material to be lodged with ease into the inner core of the needle. This structural feature is, as previously indicated, disclosed in detail in my copending patent application referred to hereinabove.

In order to provide the degree of flexibility required, the needle is fabricated from a flexible metal, such as, for example, a woven group of filament such as, for example, stainless steel or the like. In some situations, molded plastic resin materials such as, for example, molded silicone, molded polytetrafluoroethylene, or the like may be utilized.

The needle is normally encased within a sheath means such as is illustrated in FIG. I, a modified form of sheath being shown in FIG. 3 at 30. The sheath is in the form of a hollow shaft, and has a tapered distal end as at 31 terminating in a needle-accommodating tip 32. If desired, a modified form of sheath such as is illustrated in FIG. 8 may be employed, as will be more fully discussed hereinafter.

The sheath means, when employed, is preferably flexible and is resistant to temperatures encountered during use. For example, the material, if sued in combination with the microcauter illustrated in FIG. 6, the structure should be capable of withstanding the temperatures to which it is exposed. The same situation is, of course, appropriate for use with the cryoprobe disclosed in FIG. 7. In most instances, the sheath may be fabricated from the same materials discussed in connection with the needle portion of the device disclosed in FIG. 2.

The stylet 13, as illustrated in FIG. 4, includes a shank or shaft portion 40 having a tissue penetrating tip 41 and a locking proximal portion shown at 42. As is conventional, the lock, which is the form of a bayonet lock, is utilized to firmly secure and adhere the stylet to the needle member 20. The channels illustrated in the locking head portion 22 will, of course, accommodate the locking pins illustrated at 43 in FIG. 4.

It will be appreciated that the stylet should be fabricated from a hard material such as stainless steel or the like, and is provided with a structure for fitting exactly within the tip of the needle, the sharp tip of the stylet extending beyond the beveled tip of the needle approximately 1 to 2 millimeters. If desired, as an alternative, the tip portion of the stylet may be in the form of an auger screw in order to penetrate hard material.

Reference is now made to FIG. 5 wherein a probe is illustrated at 50, this probe being adapted to be inserted within the tip portion 21 of the needle and used to urge or drive any retained material axially outwardly through the proximal end of the needle 12. The length of the probe exceeds the length of the biopsy needle by a few centimeters and preferably is provided with a blunt tip.

Attention is now directed to FIG. 6 of the drawings wherein a microcauter is illustrated, the microcauter 60 including a body portion 61 along with a tip member 62 which extends a few millimeters beyond the distal end of the sheath, when in place. The microcauter further includes a means for coupling to a source of electrical current or power, such as at 63, the electrical power being utilized to heat the tip 62 to a suitable cauterizing temperature.

Attention is now directed to FIG. 7, wherein the cryoprobe generally designated 70 having a body portion or shank 71 and a tip member 72. Means are provided as at 73 for coupling the cryoprobe to a suitable source of cryogenic materials, such as, for example, liquid nitrogen or the like. With liquid nitrogen being held at equilibrium with gaseous nitrogen in ambient conditions, the liquid nitrogen cools to cryogenic temperatures, and this material may be circulated through the interior of the cryoprobe, particularly through the supply and return conduits 74 and 75, these conduits being thin-walled metallic members capable of accommodating a flow of cryogenic material such as liquid nitrogen or the like held at cryogenic temperatures. The tip of the cryoprobe such as is shown at 72 is utilized to accommodate the flow from the conduits 74 and 75, and is preferably thermally conductive so as to accept the low temperature of the cryoprobe member.

Attention is now directed to FIG. 8 wherein a modified form of sheath is provided, this sheath including the modified proximal end 81 which may be employed to accept a syringe or the like for aspirating an organ which is involved in the biopsy.

In order to take a biopsy from a potentially bleeding organ that is fixed within the body of the patient, the biopsy needle structure as illustrated in FIG. I is employed, the guard 14 being locked onto the surface of the sheath at the desired location. The needle means is then introduced into the body of the patient and the needle tip is brought into proximity to the pertinent organ. The stylet I3 is then removed and the guard is readjusted to the length of the needle needed to penetrate into the organ involved, at which time the needle is introduced into the organ either by using a stabbing push or by using a source of rotational energy or motion derived from an electric drill, for example, coupled or interlocked to the proximal end of the needle. If desired, the needle may be introduced into the organ by utilizing an auger tip on a stylet, if indicated. After the needle has been introduced into the organ to a length determined by the second locking position of the guard, the needle is removed from the sheath, leaving the sheath behind in the organ. The biopsy needle containing the biopsy material is then set aside. Thereafter, either the microcauter illustrated in FIG. 6 or the cryoprobe illustrated in FIG. 7 is introduced into the sheath. At this time, the source of electrical power is applied in order to cause the tip of the microcauter to achieve cauterizing temperature, or, if the cryoprobe is utilized, a source of cryogenic material is introduced into the structure to cool the tip of the cryoprobe. At this point, the sheath with the already secured microcauter or cryoprobe is slowly removed from the organ so that cauterization or cooling of the biopsy tract is secured, thus preventing the organ from internal hemorrhaging or bleeding. The biopsy material already lodged in the tip of the needle is then removed with the probe 50, and processed for the appropriate determinations or studies.

. In order to utilize the structure of the present invention for the purpose of taking biopsy from an organ that is potentially a bleeder and is nonfixed or moves with respiration of the patient, such as spleen or the like, the procedure is similar to that disclosed hereinabove, except that the needle is inserted into the organ and thereafter immediately removed leaving the flexible sheath behind. Since the sheath is reasonably flexible, it will bend according to the movement of the organ involved and will not cause damage to occur. The biopsy tract is similarly cauterized or frozen using the flexible microcauter or flexible cyroprobe.

In performing the cauterizing or freezing of the biopsy tract, particularly when potentially movable organs are involved, it is important that the shaft portions of the microcauter and cryoprobe be flexible in order to accommodate this relative motion.

In order to take a biopsy from an organ that may move and is not potentially a bleeder, the speed for taking the material is of primary importance. In this instance, the axially flexible biopsy needle is utilized without the sheath, with the stylet and guard in proper disposition. The needle together with the stylet is then introduced into the skin and brought into the proximity of the organ involved. The stylet is then removed from the needle and the needle is then prepared for advancement or introduction into the organ. If desired, a rotating drill may be utilized to cause rotation of the needle as it is being introduced into the organ, where appropriate. At any rate, the stylet is removed and if rotational energy is utilized, it is accomplished with a stabbing push to introduce the needle into the organ to the desired length which is determined or defined by the position of the guard, and then the needle is immediately withdrawn with the obtaining of the predetermined quantity of biopsy material. For obtaining the rotational energy, a drill head may be utilized which is'lockingly engaged to the locking lugs which are present at the proximal end of the needle portion of the apparatus as shown in FlG. 2. The drill has a rotational velocity capability in the area of about 3,600 r.p.m., and may be powered by conventional electrical current means, or by a suitable source of battery power. This procedure normally will not require more than a few seconds and can be accomplished without difficulty. I

It has been indicated that the needle is generally flexible, and this of course is preferred. However, in order to facilitate and improve the insertion characteristics of the needle, the tip end may be fabricated from a sharpened metal such as, for example, stainless steel or the like. This tip may be molded in situ with the needle proper.

in order to aspirate tissue of blood from an organ, the needle is introduced into the organ to the extent desired, and when adequate biopsy material has been obtained, a syringe is attached to the modified sheath such as is illustrated in FIG. 8, and the biopsy material is then aspirated through the syringe. If the organ involved is potentially a bleeder, then the biopsy tract is counterized or frozen as described hereinabove.

It will be appreciated that the structural details illustrated herein are illustrative of various embodiments which may be fabricated by those skilled in the art.

, What is claimed is: l 1. An elongate hollow biopsy needle having opened distal and proximal ends, said distal end defining a cutting edge,

a. said needle having substantial axial flexure and being of uniform hollow cylindrical configuration throughout the major portion of its length, and having an external distal end surface portion tapered generally uniformly uninterrupted toward the tip of the distal end, and an internal end surface portion tapering generally uniformly, uninterrupted, toward the tip of the distal end defining an inner biopsy tissue receiving and retaining bore immediately adjacent the distal end and with the needle converging from a first circular diameter which extends along the major portion of the length of the needle toward and to second and significantly smaller circular diameter at the distal end, a rigid elongate stylet having substantially less axial flexure than said needle and being positioned within said needle and corresponding generally in length and shape to the bore formed in said needle, said stylet being of uniformly cylindrical configuration throughout a major portion of its length, and having a uniformly uninterrupted tapered distal end portion converging to a closed distal end tip;

b. means arranged on said needle and stylet to position the stylet within said needle so that the distal ends of the generally flexible needle and rigid stylet cooperate with each other to present a symmetrical closed tip end whereby said needle and stylet may be inserted as a unit into a tissue, and when said stylet is removed from the needle after insertion into a tissue, and upon manipulation of the needle, the distal cutting end of the generally flexible needle will cut a tissue sample and the tissue sample will be collected in the expanded distal end portion of the bore of the needle to thereby minimize damage to the tissue.

2. The biopsy needle means as defined in claim 1 being particularly characterized in that sheath means are provided, coupled to said needle and disposed about the outer surface of said needle, said sheath means having a central bore therein for receiving, in coaxial disposition therewithin, said biopsy needle and stylet means, said sheath being formed from axially flexible material with flexural characteristics substantially matching the flexural characteristics of said needle.

3. The biopsy needle means as defined in claim 2 being particularly characterized in that guard means are provided for releasably locking engagement withthe surface of said sheath.

4. The biopsy needle means as defined in claim 2 being particularl characterized in that the bore of said sheath is adapte to receive microcauter means,'and microcauter means are received within said sheath, said microcauter means including a cauterizing tip which extends axially outwardly beyond the distal end of said sheath.

5. The biopsy needle means as defined in claim 2 being particularly characterized in that the bore of said sheath is adapted to receive cryoprobe means, and cryoprobe means are received within said sheath, said cryoprobe means including a freezing tip which extends axially outwardly beyond the distal end of said sheath.

6. The biopsy needle means as defined in claim 1 being particularly characterized in that guard means are provided for lockingly engaging the surface of said needle.

7. The biopsy needle means as defined in claim 1 being particularly characterized in that the proximal end of said needle is provided with means adapted for releasably locking engagement with a powered source of rotational energy.

8. The biopsy needle device as defined in claim 1 being particularly characterized in that said needle is fabricated from stainless steel filaments woven together to form a tubular needle structure.

9. The biopsy needle device as defined in claim 1 being par ticularly characterized in that said needle is fabricated from molded silicone.

10. The biopsy needle device as defined in claim I being particularly characterized in that said needle is fabricated from molded polytetrafluoroethylene. 

2. The biopsy needle means as defined in claim 1 being particularly characterized in that sheath means are provided, coupled to said needle and disposed about the outer surface of said needle, said sheath means having a central bore therein for receiving, in coaxial disposition therewithin, said biopsy needle and stylet means, said sheath being formed from axially flexible material with flexural characteristics substantially matching the flexural characteristics of said needle.
 3. The biopsy needle means as defined in claim 2 being particularly characterized in that guard means are provided for releasably locking engagement with the surface of said sheath.
 4. The biopsy needle means as defined in claim 2 being particularly characterized in that the bore of said sheath is adapted to receive microcauter means, and microcauter means are received within said sheath, said microcauter means including a cauterizing tip which extends axially outwardly beyond the distal end of said sheath.
 5. The biopsy needle means as defined in claim 2 being particularly characterized in that the bore of said sheath is adapted to receive cryoprobe means, and cryoprobe means are received within said sheath, said cryoprobe means including a freezing tip which extends axially outwardly beyond the distal end of said sheath.
 6. The biopsy needle means as defined in claim 1 being particularly characterized in that guard means are provided for lockingly engaging the surface of said needle.
 7. The biopsy needle means as defined in claIm 1 being particularly characterized in that the proximal end of said needle is provided with means adapted for releasably locking engagement with a powered source of rotational energy.
 8. The biopsy needle device as defined in claim 1 being particularly characterized in that said needle is fabricated from stainless steel filaments woven together to form a tubular needle structure.
 9. The biopsy needle device as defined in claim 1 being particularly characterized in that said needle is fabricated from molded silicone.
 10. The biopsy needle device as defined in claim 1 being particularly characterized in that said needle is fabricated from molded polytetrafluoroethylene. 